Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream (4%, 6%, 8%) for the Treatment of Presbyopia

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Multicenter, Randomized, Double-Masked Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaukos Corporation
• Treatments: Pilocarpine

Criteria

Inclusion Criteria:

• Presbyopic male or female 40-55 years of age

• Willing and able to provide written informed consent on the IRB/IEC approved informed consent form

Exclusion Criteria:

• Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation

• History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products

• History of, or active, iritis or uveitis in either eye

• Pre-existing retinal diseases in either eye that may pre-dispose the subjects to retinal detachment